TDMS Study 99022-02 Pathology Tables
NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 FINAL #2; REVISION #1 MICE Facility: Southern Research Institute Chemical CAS #: 30516-87-1 Lock Date: 06/20/02 Cage Range: All Reasons For Removal: All Removal Date Range: All Treatment Groups: Merge 006 006,016 Merge 007 007,017 Merge 008 008,018 Merge 009 009,019 Merge 010 010,020 Merge 001 001,011 Merge 002 002,012 Merge 003 003,013 Merge 004 004,014 Merge 005 005,015 a Number of animals examined microscopically at site and number of animals with lesion Page 1 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE FEMALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 40 42 Early Deaths Moribund Sacrifice 16 18 11 11 15 Natural Death 14 13 15 9 8 Accidently Killed 1 Survivors Moribund Sacrifice 1 1 Terminal Sacrifice 19 17 24 19 18 Natural Death 1 1 Animals Examined Microscopically 50 50 50 40 42 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (50) (49) (49) (39) (42) Edema 1 (2%) 1 (2%) 1 (2%) Intestine Large, Cecum (47) (48) (45) (38) (40) Amyloid Deposition 1 (2%) Edema 3 (6%) 3 (6%) 4 (9%) 4 (11%) 8 (20%) Intestine Small, Duodenum (50) (50) (48) (40) (42) Amyloid Deposition 1 (2%) Erosion 1 (2%) 1 (2%) 2 (5%) Ulcer 2 (4%) 1 (2%) Epithelium, Hyperplasia 12 (24%) 7 (14%) 12 (25%) 4 (10%) 9 (21%) Intestine Small, Jejunum (46) (49) (46) (40) (40) Amyloid Deposition 1 (2%) Epithelium, Hyperplasia 1 (2%) 1 (2%) 1 (3%) Intestine Small, Ileum (47) (48) (45) (38) (40) Amyloid Deposition 1 (2%) Liver (50) (50) (50) (40) (42) Amyloid Deposition 1 (2%) 1 (3%) Angiectasis 1 (2%) Basophilic Focus 1 (2%) 1 (2%) Cyst 2 (4%) 1 (2%) 1 (3%) Eosinophilic Focus 1 (2%) 2 (4%) 3 (6%) 1 (3%) 3 (7%) Hematopoietic Cell Proliferation 8 (16%) 5 (10%) 5 (10%) 5 (13%) 8 (19%) Hyperplasia, Lymphoid 3 (8%) Infiltration Cellular, Mixed Cell 7 (14%) 6 (12%) 6 (12%) 9 (23%) 9 (21%) Necrosis, Focal 6 (12%) 8 (16%) 5 (10%) 4 (10%) 6 (14%) Regeneration 1 (2%) 1 (2%) Thrombosis 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE FEMALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Hepatocyte, Hypertrophy 1 (2%) 6 (12%) 3 (6%) 2 (5%) 2 (5%) Hepatocyte, Vacuolization Cytoplasmic 1 (2%) 3 (6%) 2 (5%) Kupffer Cell, Hyperplasia 1 (2%) 1 (2%) 1 (3%) 2 (5%) Kupffer Cell, Pigmentation 4 (8%) 4 (8%) 2 (4%) 6 (15%) 6 (14%) Mesentery (4) (8) (7) (3) (5) Angiectasis 1 (14%) Hemorrhage 1 (25%) 1 (13%) 1 (33%) Thrombosis 1 (25%) Fat, Necrosis 5 (63%) 4 (57%) 2 (67%) 3 (60%) Pancreas (50) (49) (49) (40) (41) Atrophy 1 (2%) 1 (3%) Edema 2 (4%) 1 (2%) 1 (2%) Necrosis, Focal 1 (2%) Acinus, Cytoplasmic Alteration 4 (8%) 2 (5%) 4 (10%) Salivary Glands (50) (49) (49) (40) (42) Hyperplasia, Lymphoid 2 (4%) 6 (12%) 3 (6%) 1 (3%) 4 (10%) Stomach, Forestomach (50) (50) (49) (40) (42) Edema 1 (2%) 5 (10%) 3 (6%) 2 (5%) 4 (10%) Erosion 2 (5%) Epithelium, Hyperplasia 4 (8%) 3 (6%) 2 (5%) 4 (10%) Stomach, Glandular (50) (50) (49) (40) (42) Amyloid Deposition 1 (2%) Cyst 2 (4%) Edema 2 (4%) 1 (2%) 2 (5%) Erosion 1 (2%) 2 (4%) 1 (2%) Infiltration Cellular, Mixed Cell 1 (2%) Glands, Hyperplasia, Cystic 6 (12%) 12 (24%) 8 (16%) 10 (25%) 6 (14%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (3) (2) Inflammation, Chronic 1 (33%) Heart (50) (49) (50) (40) (42) Amyloid Deposition 1 (2%) Cardiomyopathy 3 (6%) 2 (4%) 6 (12%) 1 (3%) 2 (5%) Inflammation, Chronic 7 (14%) 1 (2%) 2 (4%) 2 (5%) 2 (5%) Mineralization 2 (4%) 3 (6%) 2 (4%) 1 (3%) 2 (5%) Thrombosis 3 (6%) 1 (2%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE FEMALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Adrenal Cortex (50) (49) (50) (38) (42) Accessory Adrenal Cortical Nodule 10 (20%) 8 (16%) 11 (22%) 7 (18%) 6 (14%) Amyloid Deposition 1 (2%) Hyperplasia, Diffuse 2 (4%) 1 (2%) Hypertrophy, Focal 1 (2%) Capsule, Hyperplasia 1 (2%) 1 (2%) 2 (5%) 2 (5%) Adrenal Medulla (50) (49) (50) (38) (42) Hyperplasia 1 (2%) 3 (6%) 1 (2%) Islets, Pancreatic (50) (49) (49) (40) (41) Hyperplasia 2 (4%) 5 (10%) 6 (12%) 7 (18%) 10 (24%) Pituitary Gland (50) (49) (50) (40) (42) Pars Distalis, Angiectasis 1 (2%) 1 (3%) 2 (5%) Pars Distalis, Cyst 3 (6%) 3 (8%) Pars Distalis, Hyperplasia, Focal 3 (6%) 4 (8%) 1 (2%) 2 (5%) 4 (10%) Pars Intermedia, Hyperplasia 1 (2%) 1 (2%) Thyroid Gland (50) (49) (50) (40) (42) Amyloid Deposition 1 (2%) 1 (3%) Degeneration, Cystic 26 (52%) 18 (37%) 39 (78%) 24 (60%) 29 (69%) Follicular Cell, Hyperplasia 4 (8%) 2 (4%) 5 (10%) 4 (10%) 1 (2%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Clitoral Gland (50) (50) (50) (40) (42) Cyst 22 (44%) 18 (36%) 25 (50%) 14 (35%) 12 (29%) Infiltration Cellular, Lymphocyte 1 (3%) Inflammation, Chronic 23 (46%) 19 (38%) 17 (34%) 14 (35%) 16 (38%) Ovary (50) (50) (49) (40) (42) Amyloid Deposition 1 (2%) 1 (2%) Angiectasis 1 (2%) 1 (2%) 4 (8%) 3 (8%) 4 (10%) Cyst 38 (76%) 35 (70%) 37 (76%) 28 (70%) 29 (69%) Hematocyst 1 (2%) Hemorrhage 2 (4%) 2 (4%) 7 (14%) 5 (13%) 4 (10%) Thrombosis 2 (4%) 1 (3%) 1 (2%) Bilateral, Cyst 1 (3%) Corpus Luteum, Hyperplasia 1 (2%) 1 (2%) 1 (3%) 1 (2%) Uterus (50) (50) (49) (40) (42) Angiectasis 1 (2%) 4 (8%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE FEMALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Hemorrhage 1 (2%) 1 (2%) Infiltration Cellular, Histiocyte 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (2%) Thrombosis 2 (4%) 3 (6%) 1 (2%) Endometrium, Hyperplasia, Cystic 22 (44%) 27 (54%) 29 (59%) 24 (60%) 22 (52%) Vagina (49) (49) (47) (40) (41) Cyst 2 (4%) 1 (2%) Epithelium, Hyperplasia 1 (2%) 1 (2%) 2 (4%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (40) (42) Hyperplasia 33 (66%) 24 (48%) 30 (60%) 22 (55%) 26 (62%) Myelofibrosis 1 (2%) 1 (2%) Lymph Node (14) (23) (16) (12) (16) Hematopoietic Cell Proliferation 1 (7%) 1 (4%) 2 (13%) Hemorrhage 1 (6%) Hyperplasia, Lymphoid 1 (7%) 3 (13%) 1 (8%) Hyperplasia, Plasma Cell 2 (14%) 1 (6%) Pigmentation 1 (6%) Bronchial, Hemorrhage 1 (4%) Iliac, Hematopoietic Cell Proliferation 1 (7%) 1 (4%) 1 (6%) Iliac, Hemorrhage 1 (6%) Iliac, Hyperplasia, Lymphoid 2 (9%) 2 (13%) Inguinal, Hematopoietic Cell Proliferation 1 (4%) 1 (6%) Inguinal, Hyperplasia, Lymphoid 2 (14%) 4 (17%) 2 (13%) 1 (8%) 2 (13%) Inguinal, Hyperplasia, Plasma Cell 1 (7%) Inguinal, Pigmentation 1 (4%) Lumbar, Hematopoietic Cell Proliferation 1 (7%) Lumbar, Hyperplasia, Lymphoid 1 (4%) 1 (6%) Mediastinal, Hematopoietic Cell Proliferation 1 (7%) Mediastinal, Hemorrhage 1 (7%) 1 (4%) 2 (13%) 1 (6%) Mediastinal, Hyperplasia, Lymphoid 1 (7%) 2 (9%) 1 (8%) Mediastinal, Pigmentation 1 (4%) Pancreatic, Hyperplasia, Lymphoid 1 (8%) Popliteal, Hyperplasia 1 (6%) Popliteal, Hyperplasia, Lymphoid 1 (8%) Renal, Ectasia 1 (4%) Renal, Hematopoietic Cell Proliferation 1 (4%) Renal, Hemorrhage 2 (9%) 1 (6%) Renal, Hyperplasia, Lymphoid 3 (13%) 2 (13%) Lymph Node, Mandibular (49) (47) (49) (40) (42) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE FEMALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Amyloid Deposition 1 (2%) Atrophy 2 (4%) 2 (4%) 1 (2%) 4 (10%) Ectasia 2 (4%) 1 (2%) 3 (8%) 2 (5%) Hematopoietic Cell Proliferation 7 (14%) 3 (6%) 2 (4%) 4 (10%) 6 (14%) Hemorrhage 3 (6%) 4 (9%) 5 (10%) 5 (13%) 7 (17%) Hyperplasia, Lymphoid 9 (18%) 10 (21%) 17 (35%) 10 (25%) 4 (10%) Hyperplasia, Plasma Cell 5 (10%) 3 (7%) Infiltration Cellular, Plasma Cell 2 (4%) Pigmentation 5 (10%) 4 (9%) 2 (4%) 4 (10%) 6 (14%) Lymph Node, Mesenteric (50) (48) (46) (40) (42) Atrophy 2 (4%) 4 (8%) 2 (4%) 1 (3%) 5 (12%) Ectasia 2 (4%) 3 (6%) 2 (4%) 3 (8%) 1 (2%) Hematopoietic Cell Proliferation 6 (12%) 6 (13%) 2 (4%) 3 (8%) 8 (19%) Hemorrhage 12 (24%) 10 (21%) 9 (20%) 9 (23%) 11 (26%) Hyperplasia, Lymphoid 6 (12%) 7 (15%) 9 (20%) 10 (25%) 7 (17%) Pigmentation 2 (4%) 7 (15%) 3 (7%) 2 (5%) 4 (10%) Spleen (50) (50) (49) (40) (42) Amyloid Deposition 1 (3%) Hematopoietic Cell Proliferation 31 (62%) 21 (42%) 32 (65%) 26 (65%) 29 (69%) Pigmentation 13 (26%) 24 (48%) 12 (24%) 10 (25%) 12 (29%) Lymphoid Follicle, Atrophy 4 (8%) 6 (12%) 5 (10%) 6 (15%) 4 (10%) Lymphoid Follicle, Hyperplasia 7 (14%) 3 (6%) 7 (14%) 6 (15%) 7 (17%) Thymus (49) (44) (46) (36) (42) Atrophy 7 (14%) 3 (7%) 5 (11%) 2 (6%) 4 (10%) Hemorrhage 1 (2%) 4 (9%) 2 (4%) 3 (7%) Hyperplasia, Lymphoid 7 (14%) 3 (7%) 3 (7%) 7 (19%) 2 (5%) Thrombosis 1 (3%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (50) (50) (49) (40) (42) Hyperplasia 9 (18%) 9 (18%) 8 (16%) 6 (15%) 7 (17%) Skin (50) (50) (49) (40) (42) Cyst Epithelial Inclusion 1 (3%) 2 (5%) Edema 3 (6%) 7 (14%) 7 (14%) 6 (15%) 5 (12%) Inflammation, Chronic 1 (2%) 1 (2%) 1 (3%) 1 (2%) Ulcer 8 (16%) 5 (10%) 1 (2%) 5 (13%) 3 (7%) Epidermis, Hyperplasia 7 (14%) 5 (10%) 3 (6%) 4 (10%) 3 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE FEMALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM - CONT Bone (50) (50) (50) (40) (42) Fibrous Osteodystrophy 2 (4%) 7 (14%) 9 (18%) 6 (15%) 4 (10%) Hyperostosis 1 (2%) 1 (3%) Myelofibrosis 1 (3%) Cranium, Hyperostosis 1 (2%) Femur, Callus 1 (2%) Femur, Hyperostosis 1 (3%) Skeletal Muscle (5) (2) (1) (1) (4) Inflammation, Chronic 1 (20%) 1 (100%) Thrombosis 1 (25%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (50) (50) (50) (40) (42) Compression 1 (2%) Hemorrhage 1 (2%) 1 (2%) Necrosis 1 (2%) Peripheral Nerve (7) (5) (3) (5) (6) Atrophy 1 (20%) 1 (33%) 1 (20%) Spinal Cord (50) (50) (50) (40) (42) Cyst Epithelial Inclusion 1 (2%) 1 (3%) 1 (2%) Necrosis 1 (2%) 1 (2%) 1 (3%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (49) (50) (40) (42) Amyloid Deposition 1 (2%) Edema 1 (2%) 3 (6%) 4 (8%) 1 (3%) 3 (7%) Fibrosis, Focal 1 (2%) Foreign Body 3 (6%) Hemorrhage 7 (14%) 6 (12%) 6 (12%) 2 (5%) 8 (19%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 3 (6%) 4 (10%) 1 (2%) Infiltration Cellular, Histiocyte 12 (24%) 11 (22%) 21 (42%) 12 (30%) 10 (24%) Infiltration Cellular, Mixed Cell 2 (4%) 1 (3%) 1 (2%) Inflammation, Chronic 1 (2%) 2 (5%) 2 (5%) Alveolar Epithelium, Hyperplasia 2 (4%) 2 (4%) 10 (20%) 3 (8%) 2 (5%) Nose (50) (50) (50) (40) (42) Foreign Body 2 (4%) Inflammation, Chronic 11 (22%) 2 (4%) 7 (14%) 2 (5%) 4 (10%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE FEMALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (2) (1) (2) Atrophy 1 (50%) 1 (100%) Cataract 1 (50%) Inflammation, Chronic 1 (50%) Harderian Gland (49) (49) (50) (40) (41) Atrophy 1 (2%) 1 (2%) Hyperplasia, Focal 1 (2%) 2 (5%) 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (40) (42) Amyloid Deposition 2 (4%) 1 (2%) 2 (5%) Cyst 2 (4%) 7 (14%) 5 (10%) 7 (18%) 5 (12%) Hydronephrosis 2 (4%) 7 (14%) 5 (10%) 5 (13%) 3 (7%) Infarct 1 (2%) 3 (6%) 2 (5%) Infiltration Cellular, Mixed Cell 10 (20%) 20 (40%) 15 (30%) 14 (35%) 15 (36%) Inflammation, Chronic 3 (6%) Metaplasia, Osseous 1 (2%) 2 (5%) Nephropathy 29 (58%) 31 (62%) 41 (82%) 26 (65%) 33 (79%) Renal Tubule, Accumulation, Hyaline Droplet 1 (2%) 2 (4%) 2 (4%) 3 (8%) 3 (7%) Renal Tubule, Dilatation 1 (2%) 3 (6%) 1 (3%) Renal Tubule, Necrosis 1 (2%) 1 (3%) Renal Tubule, Pigmentation 1 (2%) 1 (2%) 1 (2%) 2 (5%) 2 (5%) Urinary Bladder (50) (50) (49) (40) (42) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 3 (6%) 2 (5%) 3 (7%) Inflammation, Chronic 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE MALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ DISPOSITION SUMMARY Animals Initially In Study 50 50 50 37 32 Early Deaths Moribund Sacrifice 24 20 25 23 12 Natural Death 7 9 11 5 10 Accidently Killed 1 1 2 Survivors Terminal Sacrifice 19 20 13 7 7 Moribund Sacrifice 1 Natural Death 1 Other 1 Animals Examined Microscopically 50 50 50 37 32 ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM Intestine Large, Colon (48) (50) (49) (37) (32) Edema 2 (4%) 1 (3%) Intestine Large, Cecum (49) (49) (48) (35) (30) Edema 13 (27%) 11 (22%) 8 (17%) 14 (40%) 2 (7%) Infiltration Cellular, Lymphocyte 1 (2%) Intestine Small, Duodenum (49) (50) (49) (36) (32) Amyloid Deposition 1 (2%) Epithelium, Hyperplasia 3 (6%) 4 (8%) 4 (8%) 1 (3%) 1 (3%) Intestine Small, Jejunum (49) (50) (46) (36) (29) Amyloid Deposition 1 (2%) Epithelium, Hyperplasia 4 (8%) 2 (4%) 1 (3%) 1 (3%) Intestine Small, Ileum (49) (48) (47) (35) (30) Amyloid Deposition 1 (2%) Liver (50) (50) (50) (37) (32) Amyloid Deposition 1 (3%) Angiectasis 1 (2%) 1 (2%) 1 (3%) Basophilic Focus 2 (4%) 4 (8%) 2 (4%) 2 (5%) Cholangiofibrosis 1 (2%) Clear Cell Focus 1 (2%) 1 (2%) Cyst 2 (4%) 1 (3%) Eosinophilic Focus 3 (6%) 2 (4%) 2 (4%) 1 (3%) 2 (6%) Hematopoietic Cell Proliferation 9 (18%) 7 (14%) 12 (24%) 6 (16%) 5 (16%) Hemorrhage 1 (2%) 1 (2%) 1 (3%) Hyperplasia, Lymphoid 1 (2%) Infarct 1 (3%) Infiltration Cellular, Mixed Cell 10 (20%) 7 (14%) 2 (4%) 5 (14%) 2 (6%) a Number of animals examined microscopically at site and number of animals with lesion Page 9 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE MALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ ALIMENTARY SYSTEM - CONT Necrosis, Focal 8 (16%) 9 (18%) 7 (14%) 4 (11%) 3 (9%) Regeneration 1 (2%) 1 (3%) Tension Lipidosis 1 (2%) 1 (3%) Centrilobular, Necrosis 2 (4%) 1 (2%) Hepatocyte, Hypertrophy 15 (30%) 15 (30%) 9 (18%) 6 (16%) 15 (47%) Hepatocyte, Vacuolization Cytoplasmic 1 (2%) 1 (2%) 2 (4%) 1 (3%) Hepatocyte, Centrilobular, Vacuolization Cytoplasmic 1 (3%) Kupffer Cell, Hyperplasia 2 (4%) 1 (3%) 1 (3%) Kupffer Cell, Pigmentation 2 (4%) 3 (6%) 2 (5%) 3 (9%) Mesentery (1) (2) (3) (1) Hemorrhage 1 (50%) 1 (100%) Fat, Necrosis 1 (50%) 3 (100%) Pancreas (50) (50) (50) (37) (31) Atrophy 1 (2%) Cyst 1 (3%) Edema 1 (2%) 2 (4%) 2 (5%) Infiltration Cellular, Mixed Cell 1 (3%) Acinus, Cytoplasmic Alteration 1 (2%) 2 (4%) 1 (2%) 1 (3%) 1 (3%) Salivary Glands (50) (50) (50) (37) (32) Atrophy 1 (2%) 1 (3%) Hyperplasia, Lymphoid 1 (3%) Infiltration Cellular, Lymphoid 1 (2%) 5 (16%) Infiltration Cellular, Mixed Cell 1 (2%) 1 (2%) 2 (5%) Stomach, Forestomach (49) (50) (50) (37) (32) Diverticulum 1 (3%) Edema 1 (2%) 2 (4%) 1 (3%) Ulcer 1 (2%) Epithelium, Hyperplasia 2 (4%) 1 (2%) 1 (3%) 1 (3%) Stomach, Glandular (49) (50) (50) (37) (32) Edema 1 (2%) 2 (4%) 2 (5%) Erosion 2 (4%) 2 (4%) 1 (2%) 1 (3%) Glands, Hyperplasia, Cystic 9 (18%) 13 (26%) 10 (20%) 15 (41%) 6 (19%) Tooth (1) Malformation 1 (100%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM Blood Vessel (1) (1) (1) Inflammation, Chronic 1 (100%) Heart (50) (50) (50) (37) (32) Amyloid Deposition 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 10 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE MALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM - CONT Cardiomyopathy 12 (24%) 7 (14%) 19 (38%) 13 (35%) 7 (22%) Inflammation 1 (2%) Inflammation, Chronic 1 (2%) 5 (10%) 3 (6%) 2 (5%) 1 (3%) Mineralization 2 (4%) 1 (2%) 1 (3%) Thrombosis 2 (4%) 4 (8%) 5 (10%) 3 (8%) 3 (9%) ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (50) (50) (50) (37) (32) Accessory Adrenal Cortical Nodule 8 (16%) 9 (18%) 7 (14%) 6 (16%) 6 (19%) Amyloid Deposition 1 (2%) Hyperplasia, Focal 2 (4%) 5 (10%) 3 (6%) 2 (5%) Hypertrophy, Focal 6 (12%) 5 (10%) 4 (8%) 4 (11%) 4 (13%) Capsule, Hyperplasia 2 (4%) 2 (4%) 1 (2%) 3 (8%) 2 (6%) Adrenal Medulla (50) (50) (49) (37) (32) Hyperplasia 2 (4%) 1 (2%) 1 (3%) Islets, Pancreatic (50) (50) (50) (36) (31) Hyperplasia 15 (30%) 13 (26%) 12 (24%) 6 (17%) 6 (19%) Pituitary Gland (48) (49) (49) (36) (31) Pars Distalis, Cyst 1 (2%) 2 (4%) 3 (6%) 2 (6%) 1 (3%) Thyroid Gland (50) (50) (50) (37) (32) Amyloid Deposition 1 (2%) Degeneration, Cystic 29 (58%) 23 (46%) 33 (66%) 15 (41%) 15 (47%) Follicular Cell, Hyperplasia 3 (6%) 2 (4%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Coagulating Gland (2) (2) (1) (1) Bilateral, Dilatation 1 (50%) Epididymis (50) (50) (50) (37) (32) Atypia Cellular 1 (2%) 3 (6%) 3 (6%) 3 (8%) 3 (9%) Granuloma Sperm 1 (2%) Inflammation, Chronic 1 (2%) 1 (2%) Spermatocele 2 (4%) 1 (3%) Penis (2) (1) (3) (1) Inflammation, Chronic Active 2 (100%) 1 (100%) 1 (33%) a Number of animals examined microscopically at site and number of animals with lesion Page 11 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE MALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM - CONT Preputial Gland (50) (50) (50) (37) (32) Cyst 6 (12%) 7 (14%) 6 (12%) 6 (16%) 2 (6%) Inflammation, Chronic 11 (22%) 11 (22%) 18 (36%) 8 (22%) 9 (28%) Prostate (50) (50) (50) (37) (32) Inflammation, Chronic 8 (16%) 3 (6%) 12 (24%) 6 (16%) 5 (16%) Seminal Vesicle (50) (50) (50) (37) (32) Degeneration 1 (2%) 1 (3%) 1 (3%) Dilatation 2 (4%) 3 (9%) Inflammation, Chronic 2 (4%) 3 (6%) 3 (8%) Testes (50) (50) (50) (37) (32) Germinal Epithelium, Atrophy 4 (8%) 7 (14%) 5 (10%) 3 (8%) 4 (13%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Bone Marrow (50) (50) (50) (37) (32) Hyperplasia 43 (86%) 29 (58%) 35 (70%) 27 (73%) 24 (75%) Infiltration Cellular, Mast Cell 1 (2%) Myelofibrosis 1 (3%) Lymph Node (12) (10) (15) (6) (2) Hematopoietic Cell Proliferation 3 (25%) 2 (20%) 1 (7%) Hyperplasia, Lymphoid 1 (8%) 3 (30%) 2 (13%) 2 (33%) Hyperplasia, Plasma Cell 3 (25%) 2 (100%) Bronchial, Hyperplasia, Lymphoid 1 (10%) Iliac, Hyperplasia, Lymphoid 1 (7%) 1 (17%) Iliac, Pigmentation 1 (7%) Inguinal, Hematopoietic Cell Proliferation 1 (8%) 1 (7%) 1 (17%) Inguinal, Hyperplasia, Lymphoid 2 (17%) 1 (10%) 6 (40%) 1 (17%) Inguinal, Hyperplasia, Plasma Cell 2 (17%) Inguinal, Pigmentation 1 (7%) Lumbar, Pigmentation 1 (7%) Mediastinal, Hemorrhage 1 (8%) Mediastinal, Hyperplasia, Lymphoid 3 (20%) Renal, Hyperplasia, Lymphoid 1 (8%) 1 (17%) Renal, Hyperplasia, Plasma Cell 1 (8%) Lymph Node, Mandibular (50) (50) (49) (37) (32) Atrophy 1 (2%) 3 (8%) Ectasia 2 (4%) 1 (2%) 1 (3%) 2 (6%) Hematopoietic Cell Proliferation 7 (14%) 6 (12%) 4 (11%) 5 (16%) Hemorrhage 3 (6%) Hyperplasia, Lymphoid 11 (22%) 7 (14%) 9 (18%) 6 (16%) 9 (28%) Hyperplasia, Plasma Cell 11 (22%) 9 (18%) 6 (12%) 3 (8%) 4 (13%) Pigmentation 1 (2%) 1 (2%) a Number of animals examined microscopically at site and number of animals with lesion Page 12 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE MALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM - CONT Lymph Node, Mesenteric (50) (49) (49) (36) (32) Atrophy 1 (2%) 2 (4%) 3 (8%) Ectasia 2 (4%) 7 (14%) 3 (6%) 6 (17%) 2 (6%) Hematopoietic Cell Proliferation 12 (24%) 3 (6%) 8 (16%) 3 (8%) 4 (13%) Hemorrhage 7 (14%) 14 (29%) 17 (35%) 8 (22%) 9 (28%) Hyperplasia, Lymphoid 15 (30%) 16 (33%) 9 (18%) 10 (28%) 6 (19%) Infiltration Cellular, Histiocyte 1 (2%) Necrosis 1 (2%) 1 (2%) 3 (6%) Pigmentation 1 (2%) 1 (2%) 1 (2%) 1 (3%) Spleen (49) (50) (50) (37) (32) Hematopoietic Cell Proliferation 31 (63%) 29 (58%) 27 (54%) 18 (49%) 20 (63%) Pigmentation 2 (4%) 3 (6%) 4 (8%) 2 (5%) Lymphoid Follicle, Atrophy 4 (8%) 5 (10%) 5 (10%) 7 (19%) 2 (6%) Lymphoid Follicle, Hyperplasia 6 (12%) 5 (10%) 2 (5%) 1 (3%) Thymus (48) (45) (47) (33) (32) Atrophy 15 (31%) 12 (27%) 15 (32%) 13 (39%) 7 (22%) Cyst 2 (4%) 1 (2%) 2 (4%) 1 (3%) 1 (3%) Hyperplasia, Lymphoid 1 (2%) 1 (2%) 6 (13%) 1 (3%) 6 (19%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (50) (50) (50) (37) (32) Cyst Epithelial Inclusion 2 (4%) 1 (3%) Edema 10 (20%) 2 (4%) 7 (14%) 7 (19%) 1 (3%) Ulcer 14 (28%) 14 (28%) 13 (26%) 7 (19%) 6 (19%) Epidermis, Hyperplasia 13 (26%) 12 (24%) 12 (24%) 8 (22%) 5 (16%) Epidermis, Inflammation 1 (2%) 1 (2%) Epidermis, Ulcer 1 (2%) Subcutaneous Tissue, Edema 1 (2%) 1 (2%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (50) (50) (50) (37) (32) Fibrous Osteodystrophy 1 (2%) 1 (3%) 1 (3%) Fracture 1 (3%) Femur, Osteopetrosis 1 (2%) 2 (6%) Scapula, Osteopetrosis 1 (3%) Skeletal Muscle (1) (2) (1) (3) (2) Hemorrhage 1 (100%) Pigmentation 1 (33%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 13 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE MALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Brain (49) (50) (50) (37) (32) Hydrocephalus 1 (2%) Necrosis 1 (3%) Spinal Cord (50) (50) (50) (37) (32) Cyst Epithelial Inclusion 1 (2%) 1 (3%) Demyelination 1 (3%) Infiltration Cellular, Mast Cell 1 (2%) Necrosis 1 (2%) 1 (2%) 1 (3%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (50) (50) (50) (37) (32) Congestion 1 (3%) Edema 1 (2%) 2 (4%) 4 (11%) Fibrosis, Focal 1 (2%) Foreign Body 1 (2%) 1 (2%) 1 (3%) 1 (3%) Hemorrhage 5 (10%) 3 (6%) 7 (14%) 5 (14%) 2 (6%) Hyperplasia, Lymphoid 1 (2%) 1 (3%) 1 (3%) Infiltration Cellular, Histiocyte 12 (24%) 16 (32%) 13 (26%) 16 (43%) 14 (44%) Inflammation, Chronic 2 (4%) 1 (2%) 5 (10%) 2 (5%) 1 (3%) Thrombosis 1 (2%) 1 (2%) Alveolar Epithelium, Hyperplasia 6 (12%) 3 (6%) 1 (3%) 4 (13%) Nose (50) (50) (50) (36) (32) Foreign Body 1 (2%) 1 (2%) 1 (2%) Inflammation, Chronic 5 (10%) 5 (10%) 5 (10%) 3 (8%) 4 (13%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Harderian Gland (50) (50) (49) (37) (32) Hyperplasia, Focal 2 (4%) 1 (2%) 1 (3%) 1 (3%) Hypertrophy, Focal 1 (2%) Inflammation 1 (2%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (50) (50) (50) (37) (32) Amyloid Deposition 3 (6%) Cyst 27 (54%) 23 (46%) 26 (52%) 24 (65%) 17 (53%) a Number of animals examined microscopically at site and number of animals with lesion Page 14 NTP Experiment-Test: 99022-02 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: PERINATAL EXPOS AZT TRANSPLACENTAL CARCINOGENESIS STUDY Date: 09/09/04 Route: IN-UTERO Time: 14:01:32 ____________________________________________________________________________________________________________________________________ SWISS MICE MALE 0 50 100 200 300 MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY MG/KG/DY ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Hydronephrosis 30 (60%) 20 (40%) 17 (34%) 16 (43%) 14 (44%) Infarct 1 (2%) 1 (3%) 1 (3%) Infiltration Cellular, Mixed Cell 9 (18%) 11 (22%) 17 (34%) 9 (24%) 12 (38%) Inflammation, Chronic 1 (2%) 2 (4%) 1 (2%) 2 (5%) Inflammation, Suppurative 4 (8%) Metaplasia, Osseous 1 (2%) 1 (2%) 1 (2%) Mineralization 1 (2%) 1 (3%) Nephropathy 40 (80%) 40 (80%) 42 (84%) 30 (81%) 23 (72%) Renal Tubule, Dilatation 1 (2%) 5 (10%) 2 (5%) 1 (3%) Renal Tubule, Necrosis 3 (6%) 1 (3%) Renal Tubule, Pigmentation 1 (2%) 2 (4%) 2 (5%) Ureter (3) (1) (1) Dilatation 2 (67%) 1 (100%) 1 (100%) Urethra (1) (4) (5) (3) (3) Angiectasis 1 (100%) 3 (60%) 1 (33%) 1 (33%) Inflammation, Chronic 1 (100%) 1 (25%) 3 (60%) 1 (33%) Bulbourethral Gland, Cyst 1 (25%) 2 (40%) 1 (33%) 2 (67%) Urinary Bladder (50) (50) (50) (37) (32) Edema 1 (2%) 2 (6%) Hemorrhage 3 (6%) 2 (5%) 2 (6%) Inflammation, Chronic 4 (8%) 2 (4%) 1 (3%) 1 (3%) Transitional Epithelium, Hyperplasia 4 (8%) 1 (2%) 3 (6%) 1 (3%) 1 (3%) a Number of animals examined microscopically at site and number of animals with lesion Page 15 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------